Subcutaneous SHR-1316 combined with carboplatin and etoposide for extensive-stage small cell lung cancer

An Open Label, Multicenter Phase I Clinical Study on the Pharmacokinetics, Safety, Tolerability, and Efficacy of SHR-1316 (SC) Combined With Carboplatin and Etoposide in First-line Treatment of Extensive Stage Small Cell Lung Cancer

This test tries adding subcutaneous SHR-1316 to carboplatin and etoposide for people with extensive-stage small cell lung cancer who have not had first-line systemic therapy.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Nanchang, Jiangxi)
• Trial ID: NCT07009457 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label Phase I trial led by Suzhou Suncadia gives subcutaneous SHR-1316 together with standard carboplatin and etoposide as first-line therapy for extensive-stage small cell lung cancer. It will enroll patients with histologically or cytologically confirmed ES-SCLC who are treatment-naive to first-line systemic therapy, have ECOG 0–1, and at least one measurable lesion per RECIST v1.1. The study's primary focus is on the pharmacokinetics, tolerability, safety, and immunogenicity of the subcutaneous formulation, with planned monitoring of laboratory values and adverse events. Exploratory outcomes include initial anti-tumor activity observed by imaging and response criteria.

Who should consider this trial

Good fit: Adults with confirmed extensive-stage SCLC who have not received first-line systemic therapy or immune checkpoint inhibitors, have ECOG performance status 0–1, at least one measurable lesion, adequate organ and marrow function, and an expected survival of at least 12 weeks.

Not a fit: Patients with untreated or symptomatic central nervous system or meningeal metastases, uncontrolled spinal cord compression, symptomatic effusions requiring repeated drainage, uncontrollable tumor-related pain, prior first-line systemic therapy for ES-SCLC, or inadequate organ function are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this combination could improve tumor control and extend the time before the cancer worsens while offering a potentially more convenient subcutaneous immunotherapy option.

How similar studies have performed: Other PD-(L)1 immune checkpoint inhibitors combined with platinum–etoposide (for example atezolizumab and durvalumab) have improved outcomes in extensive-stage SCLC, so this combination approach is supported by prior success, though SHR-1316's subcutaneous formulation is novel and still under early study.

Eligibility criteria

Inclusion Criteria:

1. Patients with extensive stage small cell lung cancer confirmed by histology or cytology; Has not received first-line systemic therapy or immune checkpoint inhibitor treatment for ES-SCLC in the past.
2. ECOG physical fitness score 0-1 points.
3. According to RECIST v1.1, there must be at least one measurable tumor lesion.
4. Expected survival time ≥ 12 weeks.
5. Having sufficient bone marrow and organ function.
6. Participants must give informed consent to this study prior to the trial and voluntarily sign a written informed consent form.

Exclusion Criteria

1. Patients with central nervous system or meningeal metastases.
2. Spinal cord compression that cannot be cured by surgery and/or radiotherapy cannot be included in the study.
3. Patients diagnosed by researchers with uncontrollable tumor related pain.
4. Symptomatic third space effusion requires repeated drainage, such as pericardial effusion, pleural effusion, and abdominal effusion that cannot be controlled by pumping or other treatments.
5. Having undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to the first use of the investigational drug, or requiring elective surgery during the trial period.
6. History of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, radiation pneumonitis requiring steroid treatment, or clinically significant active pneumonia at screening; Or other moderate to severe lung diseases that seriously affect lung function (patients with a history of radiation pneumonitis (fibrosis) in the radiation area may participate in this study).
7. Severe infections, including but not limited to bacteremia requiring hospitalization and severe pneumonia, were present within 4 weeks prior to the first medication; Within 2 weeks prior to the first medication, there is an active infection with CTCAE ≥ 2 that requires treatment with systemic antibiotics.
8. Individuals with active pulmonary tuberculosis infection detected through medical history or CT examination within the year prior to enrollment, or those with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment.
9. History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplant recipients.
10. Known to have alcohol or drug dependence; Individuals with mental disorders or poor compliance; Pregnant or lactating women; Or the researcher believes that there is a history of other serious systemic diseases or other reasons that make it unsuitable to participate in this clinical study.

Where this trial is running

Nanchang, Jiangxi

• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (RECRUITING)

Study contacts

• Study coordinator: Ran Zhao

Conditions: Widespread Small Cell Lung Cancer